The UK/EU Trade and Co-operation Agreement (TCA) has ensured tariff free trade, preventing disruption of supply of medicinal products and medical devices between the EU and UK, provided that criteria relating to rules of origin are met (and with separate rules for Northern Ireland). For the life sciences industry specifically, the TCA includes provisions relating to mutual recognition of Good Manufacturing Practice (GMP) inspections and of official GMP documents. However, as one of the most heavily regulated industries, the sector must otherwise now deal with two separate and distinct legal and regulatory regimes.
Annex TBT-2 to the TCA contains a range of provisions which aim to facilitate availability of medicines in each territory, promote public health and provide for high levels of consumer and environmental protection. These provisions include mutual recognition of GMP inspections and certificates, which will prevent duplication of inspections. Whilst the TCA does not allow for regulatory equivalence more generally, it does provide for mutual consultation on the introduction of significant changes to technical regulations or inspection procedures, and co-operation through joint initiatives, proposals and approaches.
Now operating as a standalone regulator, the Medical & Healthcare Products Regulatory Agency (MHRA) has published a suite of guidance and information for relevant procedures for the UK's regulatory framework for medicinal products and medical devices from 1 January 2021. This covers areas such as clinical trials, devices, importing and exporting, licensing of medicines, pharmacovigilance and paediatrics.
In relation to medical devices, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022. The Medicines and Medical Devices Bill currently going through Parliament contains powers to update and revise the UK's regulatory framework.
Intellectual Property: SPCs
Title V of Part Two of the TCA contains a number of provisions relating to intellectual property rights. In relation to extended protection via supplementary protection certificates (SPCs), the TCA provides that the UK and EU shall each provide for such protection. However, the UK and EU can determine the terms and conditions of this, including the length of protection, in accordance with their respective laws and regulations. Accordingly, it appears there is scope for flexibility for the UK to develop its laws in relation to SPCs in the future. We discuss the impact of Brexit on SPC protection in the UK here.
Protection of data submitted to obtain a marketing authorisation
The TCA provides that the UK and EU will each protect commercially confidential information submitted to obtain a marketing authorisation, unless steps are taken to ensure that the data are protected against unfair commercial use, or where disclosure is necessary for an overriding public interest. Further, the MHRA and European Medicines Agency (EMA) will recognise rights of data exclusivity and market exclusivity. Again, there is scope for the UK to review the applicable periods of time for such rights and also the relevant conditions that apply.
Title III of Part Two of the TCA contains a number of provisions relating to digital trade. In particular, in relation to data protection, the UK and EU commit to ensuring cross-border data flows to facilitate digital trade. It provides for a for a four-month bridging period (which will extend to six months if necessary) for the EU Commission to conclude its assessment of the UK's data protection regime and whether it is adequate. During the bridging mechanism period, the UK will not be treated as a third country for the purposes of data transfers from the EEA, provided that it does not modify its data protection law (the 'UK GDPR') or exercise certain powers in relation to international transfers, unless by mutual agreement. If the EU objects to any changes or exercise of certain powers by the UK, and the UK goes ahead to make them, the bridging mechanism will come to an end. During this period, data transfers from the EEA to the UK can therefore continue without further safeguards being necessary, though it remains advisable to conduct audits of international data flows and consider appropriate transfer mechanisms to avoid any interruption to data flows at the end of the bridging period. We discuss the provisions of the TCA in relation to digital trade in more detail here.
It is clear from the numerous guidance documents issued by the MHRA that it is not looking to undertake a wholesale rewrite of the approach taken by the EU, and more specifically by the EMA. This is hardly surprising; when the EMA was located in London it worked very closely with the MHRA which was influential in the substance of the existing regulations, and the MHRA and the EMA are undoubtedly substantially of the same mind in many respects.
Also, of course, a substantially different regulatory approach to that of the EMA is likely to cause friction and inhibit closer cooperation and the movement of critical products between the UK and the EU. However, while not seeking to reinvent the wheel, the MHRA guidelines do generally indicate that some revisions will be introduced to take account of the wealth of experience that has been accumulated, and that the MHRA will take this opportunity to improve the operation of these regulations (and do so in a timeframe that the EMA would not be able to emulate). Nonetheless, the similarity in the approach is notable, and will be welcomed to ensure the future cooperation between the UK and the EU.